Poliomyelitis
Conditions
Keywords
IPV-primed, adults, vaccination, shedding, genetic stability, safety, neurovirulence, novel polio vaccine candidates
Brief summary
This study is designed to evaluate the safety and immunogenicity of two novel type 2 oral poliovirus vaccine (nOPV2) candidates (nOPV2 candidate 1 and nOPV2 candidate 2) in adults. The primary objectives of the study include the general safety and immunogenicity of the two candidate vaccines in healthy volunteers previously vaccinated with Sabin monovalent OPV or inactivated polio vaccine (IPV) only.
Detailed description
Two nOPV2 vaccine candidates have been developed as attenuated serotype 2 polioviruses derived from a modified Sabin 2 infectious complementary deoxyribonucleic acid (cDNA) clone. nOPV2 Candidate 1 (S2/cre5/S15domV/rec1/hifi3) and nOPV2 Candidate 2 (S2/S15domV/CpG40) were generated by modifying the Sabin-2 ribonucleic acid (RNA) sequence to improve phenotypic stability and make the strains less prone to reversion to virulence. The novel vaccine will eventually be licensed based on 3 criteria: a similar safety profile to the currently licensed monovalent OPV2 (mOPV2) of the Sabin strain, non-inferior immunogenicity, and reduced reversion to virulence. Due to the withdrawal of Sabin monovalent oral polio vaccine type 2 and prohibition of its use from April 2016 onward, well before the availability of nOPV2 for clinical testing, a head to head comparison of nOPV2 and mOPV2 is not possible. For these reasons, Phase 4 trials have been conducted with Sabin mOPV2 to provide control data on safety, immunogenicity, against which data for nOPV2 in subsequent Phase I and II studies will be evaluated and compared. The Phase 4 trials of Sabin mOPV2 were designed to parallel the expected design of the Phase 1 and 2 nOPV2 studies with respect to overall design, inclusion of similar study cohorts. This study is designed to evaluate the safety and immunogenicity of two novel type 2 OPV candidates in adults before testing in young children and then infants. The study will include both OPV-vaccinated and IPV-vaccinated adults to provide safety and immunogenicity data relevant to the decision to advance to future studies with testing in children who have not been exposed to OPV2. The primary objectives of the study include the general safety and immunogenicity of the two candidate vaccines, primarily based on comparison with historical data obtained in a Phase 4 study of Sabin mOPV2 for OPV-vaccinated subjects, in order to establish non-inferior immunogenicity and acceptable safety profile. Assessment of the general safety of the 2 candidate vaccines in IPV-only vaccinated participants will be based on comparison with data from a placebo group. The phase 4 control study (UAM1) used for the comparison in this study is registered with EudraCT (2015-003325-33). Participants were healthy adults aged 18-50 years with documented history of at least three polio vaccinations, including OPV, and were randomly assigned to either one dose or two doses of monovalent OPV2. Between January and March 2016, 100 volunteers were enrolled and randomly assigned to receive one or two doses of monovalent OPV2 (n=50 in each group).
Interventions
BIOLOGICALNovel OPV2 candidate 1
Live-attenuated serotype-2 poliovirus derived from a modified Sabin type-2 infectious cDNA clone and propagated in Vero cells; candidate 1 (S2/cre5/S15domV/rec1/hifi3). Modifications included the following: * Changes to the viral nucleotide sequence in part of the 5'-untranslated region to improve the genetic stability of this major attenuating determinant of Sabin type-2 to avoid reversion by single nucleotide changes. * Two modifications in the polymerase 3D to further improve stability of the attenuation and reduce frequency of recombination events * Relocation of a key replication element from the 2C coding region to the 5'-untranslated region, to inhibit recombination.
BIOLOGICALNovel OPV2 candidate 2
Live-attenuated serotype-2 poliovirus derived from a modified Sabin type-2 infectious cDNA clone and propagated in Vero cells; candidate 2 (S2/S15domV/CpG40). Modifications included the following: * Changes to the viral nucleotide sequence in part of the 5'-untranslated region to improve the genetic stability of this major attenuating determinant of Sabin type-2 to avoid reversion by single nucleotide changes. * silent non-coding modifications engineered within the capsid (VP1-4) designed to reduce replicative fitness and, potentially, to improve stability of the attenuated phenotype while also reducing transmission.
BIOLOGICALPlacebo
sugar syrup, propylene glycol (Sirupus simplex, Propylenglycolum, European Pharmacopoeia)
Sponsors
Bill and Melinda Gates Foundation
Centers for Disease Control and Prevention
PATH
Celerion
Pierre Van Damme
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All OPV-vaccinated participants will receive one of the nOPV2 candidates candidates in a single blind manner and all IPV- vaccinated participants will receive one of the nOPV2 candidates or placebo in a double-blinded manner. For the study duration participants and blinded study staff responsible for safety evaluation of IPV participants will not have any information of what has been administered. As the placebo can be distinguished from the vaccine candidates in packaging and color, reception of the vaccines, dose preparation and administration will be done by a team of unblinded study personnel. Appropriate measures will be taken at the site to ensure blinding of subjects and blinded team for the duration of the study.
Intervention model description
In this partial-blind study participants will be randomized into one of the following groups: OPV-vaccinated adults: * 1 dose of nOPV2 candidate 1 (Group 1); * 2 doses of nOPV2 candidate 1 (Group 2); * 1 dose of nOPV2 candidate 2 (Group 3); * 2 doses of nOPV2 candidate 2 (Group 4); IPV-only vaccinated adults: * 2 doses of nOPV2 candidate 1 (Group 5); * 2 doses of nOPV2 candidate 2 (Group 6); * 2 doses of placebo (Group 7). The first 100 OPV-vaccinated participants will be randomly assigned 1:1 to Groups 3 (1 dose) and 4 (2 doses) to receive nOPV2-c2. The second 100 OPV-vaccinated participants will be randomly assigned 1:1 to Groups 1 (1 dose) and 2 (2 doses) to receive nOPV2-c1. IPV-vaccinated adults will be enrolled in parallel and randomly assigned 2:1 to Group 6 (2 doses of nOPV2-c2) or Group 7 (2 doses of placebo), until Group 6 enrollment is complete, when 2:1 randomization will be continued for Group 5 (2 doses of nOPV2-c1) and Group 7 (2 doses of placebo).
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. For Groups 1, 2, 3 and 4: healthy males or females, from 18 to 50 years of age inclusive, having previously received at least 3 doses of OPV more than 12 months before the start of the study; 2. For Groups 5, 6 and 7: healthy males or females, from 18 to 50 years of age inclusive, having previously received at least 3 doses of IPV more than 12 months before the start of the study; 3. Having residence in Belgium; 4. In good physical and mental health as determined on the basis of medical history and general physical examination performed at Day 0; 5. Female subjects of childbearing potential must agree to the use of an effective method of birth control throughout the study and up to 3 months after last vaccine dose; 6. Willing to adhere to the prohibitions and restrictions specified in this protocol; 7. Informed Consent Form (ICF) and Code of Conduct signed voluntarily by the subject before any study-related procedure is performed, indicating that the subject understands the purpose of any procedures required for the study and is willing to participate in the study.
Exclusion criteria
1. A condition that, in the opinion of the Investigator, could compromise the well-being of the subject or course of the study, or prevent the subject from meeting or performing any study requirements; 2. For Groups 5, 6 and 7: ever having received any OPV in the past; 3. Any travel to polio endemic countries or countries with evidence of recent (within last 6 months) wild or vaccine-derived poliovirus circulation during the total duration of the study; 4. Professional handling of food, catering or food production activities during the total duration of the study; 5. Having Crohn's disease or ulcerative colitis or having had major surgery of the gastrointestinal tract involving significant loss or resection of the bowel; 6. A known allergy, hypersensitivity, or intolerance to the study vaccine or the placebo, or to any of their components or to any antibiotics; 7. Any confirmed or suspected immunosuppressive or immunodeficiency condition (including human immunodeficiency virus \[HIV\] infection, hepatitis B or C infections or total serum immunoglobulin A \[IgA\] level below laboratory lower limit of normal \[LLN\]); 8. Will have household or professional contact with known immunosuppressed people or people without full polio vaccination (i.e. complete primary infant immunization series), e.g. babysitting during the total duration of the study; 9. Neonatal nurses or others having professional contact with children under 6 months of age during the total duration of the study; 10. Chronic administration (i.e., longer than 14 days) of immunosuppressant drugs or other immune-modifying drugs within 6 months prior to the first vaccine dose or planned use during the study. For instance, for corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day (inhaled and topical steroids are allowed whereas intra-articular and epidural injection/administration of steroids are not allowed); 11. Presence of contraindications to administration of the study vaccine on Day 0: acute severe febrile illness deemed by the Investigator to be a contraindication for vaccination or persistent diarrhea or vomiting; 12. Indications of drug abuse or excessive use of alcohol at Day 0 (males: \> 21 units/week; females \> 14 units/week); 13. Being pregnant or breastfeeding. Women of childbearing potential will undergo a urine pregnancy test at each vaccination visit. Subjects with a positive pregnancy test will be excluded; 14. Participation in another clinical study within 28 days prior to entry in this study or receipt of any investigational product (drug or vaccine) other than the study vaccine within 28 days prior to the first administration of study vaccine, or planned use during the study period; 15. Administration of any vaccine other than the study vaccine within 28 days prior to the first dose of study vaccine and during the entire study period; 16. Administration of any polio vaccine within 12 months before the start of the study; 17. Having had a transfusion of any blood product or application of immunoglobulins within the 4 weeks prior to the first administration of study vaccine or during the study; 18. Subject is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, or is a family member of an employee or the Investigator, or was a study subject in the historical control studies UAM1 or UAT1 or in the study UAM4a (NCT03430349); 19. Having a family or household member participating in the study CVIA 065 (NCT04232943) or being a study subject in the study CVIA 065.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Up to 42 days after each vaccination | An SAE is any untoward medical occurrence that at any dose met any of the following conditions: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing inpatient hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Was medically important. A solicited AE is a pre-selected sign or symptom that occurred within 7 days after each dose, whereas unsolicited AEs were collected throughout the study. Solicited AEs included headache, fatigue, myalgia, arthralgia, paresthesia, anesthesia, paralysis, nausea, vomiting, diarrhea, abdominal pain, and fever. A severe AE is an AE that prevented normal everyday activities and which was not classified as an SAE. A related AE is an AE the investigator considered probably or possibly caused by the study vaccine, meaning that there was a reasonable temporal association or the AE was not attributable to other conditions. |
| Seroprotection Rate After a Single Dose of Novel OPV2 in Former OPV Recipients | Baseline (Day 0 prior to vaccination) and Day 28 | Seroprotection rate was defined as the percentage of participants with anti-type 2-specific poliovirus neutralizing antibody titers ≥ 1:8. Neutralizing antibodies against poliovirus type 2 were determined using the World Health Organization (WHO) standard microneutralization assay (WHO EPI GEN 93.9). The lower limit of quantitation (LLOQ) was 5.7 and the upper limit of quantitation (ULOQ) was 1448. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Unsolicited Adverse Events | Up to 42 days after each vaccination | Unsolicited events comprised other signs and symptoms that participants reported through the end of the study. Each unsolicited AE was rated on a 3-point scale of increasing intensity: * Grade 1: Mild; an AE that was easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. * Grade 2: Moderate; an AE that was sufficiently discomforting to interfere with normal everyday activities. * Grade 3: Severe; an AE that prevented normal everyday activities. Each adverse event was assessed by the investigator for causality as unrelated, unlikely, possibly, or probably related to the vaccination. |
| Number of Former OPV Recipients With Clinically Relevant Laboratory Abnormalities Up to 28 Days After Each Vaccination | Day 0, Day 7, Day 14, and Day 28 for Groups 1-4 and at Day 35, Day 42, and Day 56 for participants in Groups 2 and 4 | Laboratory assessments were collected at one-week intervals from Day 0 to Day 28 (except for Day 21) and at Days 35, 42, and 56 for participants in Groups 2 and 4 who received a 2nd dose. The Investigator reviewed laboratory values outside the normal range and assessed their clinical relevance. Any clinically relevant abnormal lab values that occurred at any visit up to 28 days after the first vaccination (in combined Groups 1 and 2 and Groups 3 and 4) and up to 28 days (Day 56) after the second dose (Groups 2 and 4) are reported. |
| Number of Former IPV Recipients With Clinically Relevant Laboratory Abnormalities Up to 28 Days After Each Vaccination | Day 0, Day 7, Day 14, Day 28, Day 35, Day 42 and Day 56 | Laboratory assessments were collected at one-week intervals from Day 0 to Day 56, except for Days 21 and 49. The Investigator reviewed laboratory values outside the normal range and assessed their clinical relevance. Any clinically relevant abnormal laboratory abnormalities that occurred at any visit up to 56 days are reported. |
| Anti-Poliovirus Type-2 Neutralizing Antibody Titers After A Single Dose of Novel OPV2 | Day 0 and Day 28 | Neutralizing antibodies against poliovirus type 2 were determined using the World Health Organization (WHO) standard microneutralization assay (WHO EPI GEN 93.9). The lower limit of quantitation (LLOQ) was 5.7 and the upper limit of quantitation (ULOQ) was 1448. Data were calculated on log2-transformed type 2 neutralizing titers and back transformed for the presentation below. Values shown as 1448 should be interpreted as ≥ 1448. |
| Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 | Up to 7 days after each dose (Day 0-7 post-dose 1 and Day 28-35 post-dose 2) | Participants were asked to complete 7-day diary cards soliciting systemic adverse events and daily oral temperature. Solicited events comprised selected signs and symptoms including headache, fatigue, myalgia, arthralgia, paresthesia, anesthesia, paralysis, nausea, vomiting, diarrhea and abdominal pain, or fever defined as a temperature of 37.5°C or higher. AEs were graded as mild (easily tolerated with minimal discomfort or temperature 37.5°C to 38.0°C), moderate (sufficiently discomforting to interfere with normal everyday activities, or temperature 38.1°C to 39.0°C), or severe (preventing normal everyday activities, or temperatures higher than 39.0°C). AEs were assessed by the investigator for causality. Probably related suggests that a reasonable temporal sequence of the AE with vaccine administration exists and, in the Investigator's clinical judgment, it is likely that a causal relationship exists between the vaccine administration and the AE, |
| Seroprotection Rate in Former IPV Recipients | Day 0, Day 28, and Day 56 | Seroprotection rate was defined as the percentage of participants with anti-type 2-specific poliovirus neutralizing antibodies titers ≥ 1:8. |
| Seroconversion Rate After a Single Dose of Novel OPV2 in Former OPV Recipients | Day 28 | Seroconversion is defined as a change from seronegative to seropositive (poliovirus type-2-specific neutralizing antibody titers ≥ 1:8), or for participants seropositive at Baseline, an antibody titer increase of ≥ 4-fold over Baseline titer. |
| Seroconversion Rate After Two Doses of Novel OPV2 in Former OPV Recipients | Day 56 | Seroconversion is defined as a change from seronegative to seropositive (poliovirus type-2-specific neutralizing antibody titers ≥ 1:8), or for participants seropositive at Baseline, an antibody titer increase of ≥ 4-fold over Baseline titer. |
| Seroconversion Rate in Former IPV Recipients | Day 28 and Day 56 | Seroconversion is defined as a change from seronegative to seropositive (poliovirus type-2-specific neutralizing antibody titers ≥ 1:8), or for participants seropositive at Baseline, a poliovirus type-2-specific neutralizing antibody titer increase of ≥ 4-fold over Baseline titer. |
| Seroprotection Rate 28 Days After Two Doses of Novel OPV2 in Former OPV Recipients | Day 56 | Seroprotection rate was defined as the percentage of participants with anti-type 2-specific poliovirus neutralizing antibodies titers ≥ 1:8. |
| Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | 7 days post-dose (Day 0-7 post-dose 1 and and Day 28-35 post-dose 2) | Participants were asked to complete 7-day diary cards soliciting systemic adverse events and daily oral temperature. Solicited events comprised selected signs and symptoms including headache, fatigue, myalgia, arthralgia, paresthesia, anesthesia, paralysis, nausea, vomiting, diarrhea and abdominal pain, or fever defined as a temperature of 37.5°C or higher. AEs were graded as mild (easily tolerated with minimal discomfort or temperature 37.5°C to 38.0°C), moderate (sufficiently discomforting to interfere with normal everyday activities, or temperature 38.1°C to 39.0°C), or severe (preventing normal everyday activities, or temperatures higher than 39.0°C). AEs were assessed by the investigator for causality. Probably related suggests that a reasonable temporal sequence of the AE with vaccine administration exists and, in the Investigator's clinical judgment, it is likely that a causal relationship exists between the vaccine administration and the AE, |
Countries
Belgium
Participant flow
Recruitment details
This study was conducted at 2 centers in Belgium. Two hundred and seventy-seven volunteers were screened between October 2018, and February 2019, and 250 participants were enrolled. Eligible participants were healthy adults aged 18-50 years with documented history of at least three polio vaccinations with either oral polio vaccine (OPV) or inactivated polio vaccine (IPV). Two novel oral polio type 2 vaccines (nOPV2) were tested: candidate 1 (nOPV2-c1) and candidate 2 (nOPV2-c2).
Pre-assignment details
The novel OPV2-c2 candidate was prioritized so the first 100 OPV-vaccinated participants were randomly assigned 1:1 to Groups 3 and 4 to receive novel OPV2-c2. The second 100 OPV-vaccinated participants were randomly assigned 1:1 to Groups 1 and 2 to receive novel OPV2-c1. IPV-vaccinated adults were enrolled in parallel and randomly assigned 2:1 to Group 6 or Group 7 until Group 6 enrollment was complete, when 2:1 randomization was continued for Group 5 and Group 7.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 1 on study Day 0. | 50 |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28). | 50 |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 Participants previously vaccinated with OPV received one dose of novel OPV2 candidate 2 on study Day 0. | 50 |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 Participants previously vaccinated with OPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28). | 50 |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 1 28 days apart (Day 0 and Day 28). | 17 |
| Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 Participants previously vaccinated with only IPV received two doses of novel OPV2 candidate 2 28 days apart (Day 0 and Day 28). | 16 |
| Group 7: IPV-vaccinated - Two Doses of Placebo Participants previously vaccinated with only IPV received two doses of placebo 28 days apart (Day 0 and Day 28). | 17 |
| Total | 250 |
Baseline characteristics
| Characteristic | Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Total | Group 7: IPV-vaccinated - Two Doses of Placebo | Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 31 years STANDARD_DEVIATION 10 | 29 years STANDARD_DEVIATION 10 | 24 years STANDARD_DEVIATION 9 | 31 years STANDARD_DEVIATION 9 | 23 years STANDARD_DEVIATION 10 | 34 years STANDARD_DEVIATION 10 | 32 years STANDARD_DEVIATION 10 | 31 years STANDARD_DEVIATION 10 |
| Number of Prior IPV Vaccinations Five | 0 Participants | 20 Participants | 5 Participants | 5 Participants | 10 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of Prior IPV Vaccinations Four | 0 Participants | 20 Participants | 10 Participants | 4 Participants | 6 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of Prior IPV Vaccinations None | 49 Participants | 190 Participants | 0 Participants | 0 Participants | 0 Participants | 47 Participants | 48 Participants | 46 Participants |
| Number of Prior IPV Vaccinations One | 1 Participants | 10 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 2 Participants | 4 Participants |
| Number of Prior IPV Vaccinations Six or more | 0 Participants | 10 Participants | 2 Participants | 7 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of Prior OPV Vaccinations Five | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Number of Prior OPV Vaccinations Four | 0 Participants | 19 Participants | 0 Participants | 0 Participants | 0 Participants | 9 Participants | 9 Participants | 1 Participants |
| Number of Prior OPV Vaccinations None | 0 Participants | 50 Participants | 17 Participants | 16 Participants | 17 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of Prior OPV Vaccinations Three | 50 Participants | 180 Participants | 0 Participants | 0 Participants | 0 Participants | 40 Participants | 41 Participants | 49 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 5 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 49 Participants | 243 Participants | 15 Participants | 16 Participants | 16 Participants | 49 Participants | 49 Participants | 49 Participants |
| Sex: Female, Male Female | 29 Participants | 149 Participants | 14 Participants | 13 Participants | 11 Participants | 32 Participants | 28 Participants | 22 Participants |
| Sex: Female, Male Male | 21 Participants | 101 Participants | 3 Participants | 3 Participants | 6 Participants | 18 Participants | 22 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 17 | 0 / 16 | 0 / 17 |
| other Total, other adverse events | 44 / 50 | 48 / 50 | 47 / 50 | 47 / 50 | 17 / 17 | 15 / 16 | 17 / 17 |
| serious Total, serious adverse events | 1 / 50 | 1 / 50 | 0 / 50 | 1 / 50 | 0 / 17 | 1 / 16 | 0 / 17 |
Outcome results
Primary
Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events
An SAE is any untoward medical occurrence that at any dose met any of the following conditions: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing inpatient hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Was medically important. A solicited AE is a pre-selected sign or symptom that occurred within 7 days after each dose, whereas unsolicited AEs were collected throughout the study. Solicited AEs included headache, fatigue, myalgia, arthralgia, paresthesia, anesthesia, paralysis, nausea, vomiting, diarrhea, abdominal pain, and fever. A severe AE is an AE that prevented normal everyday activities and which was not classified as an SAE. A related AE is an AE the investigator considered probably or possibly caused by the study vaccine, meaning that there was a reasonable temporal association or the AE was not attributable to other conditions.
Time frame: Up to 42 days after each vaccination
Population: The total vaccinated (TV) population includes all randomized participants who received at least one dose of study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe adverse events related to study vaccine | 1 Participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious or Severe adverse event | 9 Participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious solicited adverse events | 0 Participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe unsolicited adverse events | 8 Participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe solicited adverse events | 1 Participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe adverse events | 9 Participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious adverse events related to study vaccine | 0 Participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious adverse events | 1 Participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious unsolicited adverse events | 1 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious solicited adverse events | 0 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious unsolicited adverse events | 1 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious or Severe adverse event | 16 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious adverse events related to study vaccine | 0 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe adverse events | 16 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe solicited adverse events | 2 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe unsolicited adverse events | 15 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe adverse events related to study vaccine | 2 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious adverse events | 1 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe unsolicited adverse events | 4 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious unsolicited adverse events | 0 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious solicited adverse events | 0 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious adverse events related to study vaccine | 0 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious or Severe adverse event | 5 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe adverse events | 5 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe solicited adverse events | 1 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious adverse events | 0 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe adverse events related to study vaccine | 1 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious unsolicited adverse events | 1 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe unsolicited adverse events | 7 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe solicited adverse events | 2 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious adverse events | 1 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious adverse events related to study vaccine | 0 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious solicited adverse events | 0 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe adverse events related to study vaccine | 2 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious or Severe adverse event | 8 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe adverse events | 8 Participants |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe adverse events related to study vaccine | 2 Participants |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious unsolicited adverse events | 0 Participants |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious adverse events related to study vaccine | 0 Participants |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious solicited adverse events | 0 Participants |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious adverse events | 0 Participants |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe adverse events | 5 Participants |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe solicited adverse events | 1 Participants |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe unsolicited adverse events | 4 Participants |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious or Severe adverse event | 5 Participants |
| Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious adverse events | 1 Participants |
| Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe adverse events | 6 Participants |
| Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious solicited adverse events | 0 Participants |
| Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe unsolicited adverse events | 5 Participants |
| Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious unsolicited adverse events | 1 Participants |
| Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious adverse events related to study vaccine | 1 Participants |
| Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious or Severe adverse event | 6 Participants |
| Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe adverse events related to study vaccine | 5 Participants |
| Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe solicited adverse events | 1 Participants |
| Group 7: IPV-vaccinated - Two Doses of Placebo | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious adverse events | 0 Participants |
| Group 7: IPV-vaccinated - Two Doses of Placebo | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious or Severe adverse event | 10 Participants |
| Group 7: IPV-vaccinated - Two Doses of Placebo | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe unsolicited adverse events | 9 Participants |
| Group 7: IPV-vaccinated - Two Doses of Placebo | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious adverse events related to study vaccine | 0 Participants |
| Group 7: IPV-vaccinated - Two Doses of Placebo | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe adverse events related to study vaccine | 4 Participants |
| Group 7: IPV-vaccinated - Two Doses of Placebo | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe adverse events | 10 Participants |
| Group 7: IPV-vaccinated - Two Doses of Placebo | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious unsolicited adverse events | 0 Participants |
| Group 7: IPV-vaccinated - Two Doses of Placebo | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Serious solicited adverse events | 0 Participants |
| Group 7: IPV-vaccinated - Two Doses of Placebo | Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events | Severe solicited adverse events | 2 Participants |
Comparison: The number of participants with severe solicited adverse events in the OPV-vaccinated groups who received nOPV-c1 (combined Groups 1 and 2) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe solicited adverse events was 5 out of 100.p-value: 0.7209Fisher Exact
Comparison: The number of participants with severe solicited adverse events in the OPV-vaccinated groups who received nOPV-c2 (combined Groups 3 and 4) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe solicited adverse events was 5 out of 100.p-value: 0.7209Fisher Exact
Comparison: The number of participants with severe unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c1 (combined Groups 1 and 2) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe unsolicited adverse events was 17 out of 100.p-value: 0.3769Fisher Exact
Comparison: The number of participants with severe unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c2 (combined Groups 3 and 4) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe unsolicited adverse events was 17 out of 100.p-value: 0.3083Fisher Exact
Comparison: The number of participants with serious unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c1 (combined Groups 1 and 2) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with serious unsolicited adverse events was 0 out of 100.p-value: 0.4975Fisher Exact
Comparison: The number of participants with serious unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c2 (combined Groups 3 and 4) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with serious unsolicited adverse events was 0 out of 100.p-value: 1Fisher Exact
Comparison: Comparison of severe solicited adverse eventsp-value: 1Fisher Exact
Comparison: Comparison of severe solicited adverse eventsp-value: 1Fisher Exact
Comparison: Comparison of severe unsolicited adverse eventsp-value: 0.1571Fisher Exact
Comparison: Comparison of severe unsolicited adverse eventsp-value: 0.296Fisher Exact
Primary
Seroprotection Rate After a Single Dose of Novel OPV2 in Former OPV Recipients
Seroprotection rate was defined as the percentage of participants with anti-type 2-specific poliovirus neutralizing antibody titers ≥ 1:8. Neutralizing antibodies against poliovirus type 2 were determined using the World Health Organization (WHO) standard microneutralization assay (WHO EPI GEN 93.9). The lower limit of quantitation (LLOQ) was 5.7 and the upper limit of quantitation (ULOQ) was 1448.
Time frame: Baseline (Day 0 prior to vaccination) and Day 28
Population: Participants in the per-protocol population previously vaccinated with OPV. The per-protocol population excluded participants with missed doses or major protocol deviations considered to have a potential impact on immunogenicity from the time of the deviation and at all time points thereafter.~This endpoint was analyzed after one dose of nOPV hence Groups 1 and 2 and Groups 3 and 4 are combined for analysis, as specified in the study protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Seroprotection Rate After a Single Dose of Novel OPV2 in Former OPV Recipients | Day 28 | 100 percentage of participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Seroprotection Rate After a Single Dose of Novel OPV2 in Former OPV Recipients | Day 0 (pre-vaccination) | 99 percentage of participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Seroprotection Rate After a Single Dose of Novel OPV2 in Former OPV Recipients | Day 0 (pre-vaccination) | 94 percentage of participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Seroprotection Rate After a Single Dose of Novel OPV2 in Former OPV Recipients | Day 28 | 100 percentage of participants |
Comparison: The primary immunogenicity endpoint, the seroprotection rate after one dose of either vaccine candidate in the OPV-vaccinated groups (nOPV2 combined groups 1 and 2, and combined groups 3 and 4), was compared with the corresponding endpoint from the historical monovalent OPV2 (mOPV2) control study (UAM1, EudraCT # 2015-003325-33). In the UAM1 study, the observed seroprotection rate after a single dose of mOPV2 was 98% (98 out of 100 participants), with a 95% confidence interval (CI) of 93-100%.95% CI: [-1.9, 7]
Comparison: The primary immunogenicity endpoint, the seroprotection rate after one dose of either vaccine candidate in the OPV-vaccinated groups (nOPV2 combined groups 1 and 2, and combined groups 3 and 4), was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33). In the UAM1 study, the observed seroprotection rate after a single dose of mOPV2 was 98% (98 out of 100 participants), with a 95% confidence interval (CI) of 93-100%.95% CI: [-1.8, 7]
Secondary
Anti-Poliovirus Type-2 Neutralizing Antibody Titers After A Single Dose of Novel OPV2
Neutralizing antibodies against poliovirus type 2 were determined using the World Health Organization (WHO) standard microneutralization assay (WHO EPI GEN 93.9). The lower limit of quantitation (LLOQ) was 5.7 and the upper limit of quantitation (ULOQ) was 1448. Data were calculated on log2-transformed type 2 neutralizing titers and back transformed for the presentation below. Values shown as 1448 should be interpreted as ≥ 1448.
Time frame: Day 0 and Day 28
Population: Per-protocol population. The per-protocol population excluded participants with missed doses or major protocol deviations considered to have a potential impact on immunogenicity from the time of the deviation and at all time points thereafter. This endpoint was analyzed after one dose of nOPV hence Groups 1 and 2 and Groups 3 and 4 are combined for analysis, as specified in the study protocol. Samples for 2 participants in Group 5 on Day 0 were mixed up and are not included in the analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Anti-Poliovirus Type-2 Neutralizing Antibody Titers After A Single Dose of Novel OPV2 | Day 0 (pre-vaccination) | 324 titer |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Anti-Poliovirus Type-2 Neutralizing Antibody Titers After A Single Dose of Novel OPV2 | Day 28 | 1448 titer |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Anti-Poliovirus Type-2 Neutralizing Antibody Titers After A Single Dose of Novel OPV2 | Day 0 (pre-vaccination) | 455 titer |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Anti-Poliovirus Type-2 Neutralizing Antibody Titers After A Single Dose of Novel OPV2 | Day 28 | 1152 titer |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Anti-Poliovirus Type-2 Neutralizing Antibody Titers After A Single Dose of Novel OPV2 | Day 0 (pre-vaccination) | 228 titer |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Anti-Poliovirus Type-2 Neutralizing Antibody Titers After A Single Dose of Novel OPV2 | Day 28 | 1448 titer |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Anti-Poliovirus Type-2 Neutralizing Antibody Titers After A Single Dose of Novel OPV2 | Day 28 | 1448 titer |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Anti-Poliovirus Type-2 Neutralizing Antibody Titers After A Single Dose of Novel OPV2 | Day 0 (pre-vaccination) | 144 titer |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Anti-Poliovirus Type-2 Neutralizing Antibody Titers After A Single Dose of Novel OPV2 | Day 0 (pre-vaccination) | 91 titer |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Anti-Poliovirus Type-2 Neutralizing Antibody Titers After A Single Dose of Novel OPV2 | Day 28 | 51 titer |
Secondary
Number of Former IPV Recipients With Clinically Relevant Laboratory Abnormalities Up to 28 Days After Each Vaccination
Laboratory assessments were collected at one-week intervals from Day 0 to Day 56, except for Days 21 and 49. The Investigator reviewed laboratory values outside the normal range and assessed their clinical relevance. Any clinically relevant abnormal laboratory abnormalities that occurred at any visit up to 56 days are reported.
Time frame: Day 0, Day 7, Day 14, Day 28, Day 35, Day 42 and Day 56
Population: Participants in the total vaccinated population previously vaccinated with IPV only.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Former IPV Recipients With Clinically Relevant Laboratory Abnormalities Up to 28 Days After Each Vaccination | 4 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Former IPV Recipients With Clinically Relevant Laboratory Abnormalities Up to 28 Days After Each Vaccination | 6 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Former IPV Recipients With Clinically Relevant Laboratory Abnormalities Up to 28 Days After Each Vaccination | 9 Participants |
Secondary
Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2
Participants were asked to complete 7-day diary cards soliciting systemic adverse events and daily oral temperature. Solicited events comprised selected signs and symptoms including headache, fatigue, myalgia, arthralgia, paresthesia, anesthesia, paralysis, nausea, vomiting, diarrhea and abdominal pain, or fever defined as a temperature of 37.5°C or higher. AEs were graded as mild (easily tolerated with minimal discomfort or temperature 37.5°C to 38.0°C), moderate (sufficiently discomforting to interfere with normal everyday activities, or temperature 38.1°C to 39.0°C), or severe (preventing normal everyday activities, or temperatures higher than 39.0°C). AEs were assessed by the investigator for causality. Probably related suggests that a reasonable temporal sequence of the AE with vaccine administration exists and, in the Investigator's clinical judgment, it is likely that a causal relationship exists between the vaccine administration and the AE,
Time frame: 7 days post-dose (Day 0-7 post-dose 1 and and Day 28-35 post-dose 2)
Population: Participants in the total vaccinated population previously vaccinated with IPV only.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Any solicited adverse events | 16 Participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Moderate | 4 Participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Probably related to vaccination | 9 Participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Severe | 1 Participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Mild | 11 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Mild | 8 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Moderate | 3 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Severe | 0 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Any solicited adverse events | 11 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Probably related to vaccination | 8 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Severe | 0 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Any solicited adverse events | 13 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Mild | 6 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Moderate | 7 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Probably related to vaccination | 5 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Mild | 3 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Probably related to vaccination | 8 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Moderate | 5 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Severe | 1 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Any solicited adverse events | 9 Participants |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Mild | 9 Participants |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Severe | 2 Participants |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Probably related to vaccination | 9 Participants |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Moderate | 4 Participants |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Any solicited adverse events | 15 Participants |
| Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Moderate | 5 Participants |
| Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Mild | 7 Participants |
| Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Severe | 0 Participants |
| Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Probably related to vaccination | 5 Participants |
| Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Former IPV Recipients With Solicited Adverse Events After Vaccination With Novel OPV2 | Any solicited adverse events | 12 Participants |
Secondary
Number of Former OPV Recipients With Clinically Relevant Laboratory Abnormalities Up to 28 Days After Each Vaccination
Laboratory assessments were collected at one-week intervals from Day 0 to Day 28 (except for Day 21) and at Days 35, 42, and 56 for participants in Groups 2 and 4 who received a 2nd dose. The Investigator reviewed laboratory values outside the normal range and assessed their clinical relevance. Any clinically relevant abnormal lab values that occurred at any visit up to 28 days after the first vaccination (in combined Groups 1 and 2 and Groups 3 and 4) and up to 28 days (Day 56) after the second dose (Groups 2 and 4) are reported.
Time frame: Day 0, Day 7, Day 14, and Day 28 for Groups 1-4 and at Day 35, Day 42, and Day 56 for participants in Groups 2 and 4
Population: Participants in the total vaccinated population previously vaccinated with OPV.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Former OPV Recipients With Clinically Relevant Laboratory Abnormalities Up to 28 Days After Each Vaccination | 28 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Former OPV Recipients With Clinically Relevant Laboratory Abnormalities Up to 28 Days After Each Vaccination | 18 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Former OPV Recipients With Clinically Relevant Laboratory Abnormalities Up to 28 Days After Each Vaccination | 30 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Former OPV Recipients With Clinically Relevant Laboratory Abnormalities Up to 28 Days After Each Vaccination | 15 Participants |
Secondary
Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2
Participants were asked to complete 7-day diary cards soliciting systemic adverse events and daily oral temperature. Solicited events comprised selected signs and symptoms including headache, fatigue, myalgia, arthralgia, paresthesia, anesthesia, paralysis, nausea, vomiting, diarrhea and abdominal pain, or fever defined as a temperature of 37.5°C or higher. AEs were graded as mild (easily tolerated with minimal discomfort or temperature 37.5°C to 38.0°C), moderate (sufficiently discomforting to interfere with normal everyday activities, or temperature 38.1°C to 39.0°C), or severe (preventing normal everyday activities, or temperatures higher than 39.0°C). AEs were assessed by the investigator for causality. Probably related suggests that a reasonable temporal sequence of the AE with vaccine administration exists and, in the Investigator's clinical judgment, it is likely that a causal relationship exists between the vaccine administration and the AE,
Time frame: Up to 7 days after each dose (Day 0-7 post-dose 1 and Day 28-35 post-dose 2)
Population: Participants in the total vaccinated population previously vaccinated with OPV.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 | Mild | 45 Participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 | Any solicited adverse event | 71 Participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 | Moderate | 23 Participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 | Severe | 3 Participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 | Probably related to vaccination | 44 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 | Moderate | 8 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 | Any solicited adverse event | 26 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 | Mild | 18 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 | Severe | 0 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 | Probably related to vaccination | 15 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 | Moderate | 12 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 | Any solicited adverse event | 74 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 | Probably related to vaccination | 37 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 | Severe | 2 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 | Mild | 60 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 | Any solicited adverse event | 21 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 | Moderate | 6 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 | Probably related to vaccination | 12 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 | Severe | 1 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Former OPV Recipients With Solicited Adverse Events Within 7 Days of Vaccination With Novel OPV2 | Mild | 14 Participants |
Secondary
Number of Participants With Unsolicited Adverse Events
Unsolicited events comprised other signs and symptoms that participants reported through the end of the study. Each unsolicited AE was rated on a 3-point scale of increasing intensity: * Grade 1: Mild; an AE that was easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. * Grade 2: Moderate; an AE that was sufficiently discomforting to interfere with normal everyday activities. * Grade 3: Severe; an AE that prevented normal everyday activities. Each adverse event was assessed by the investigator for causality as unrelated, unlikely, possibly, or probably related to the vaccination.
Time frame: Up to 42 days after each vaccination
Population: Total vaccinated population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Participants With Unsolicited Adverse Events | Probably related to vaccination | 2 Participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Participants With Unsolicited Adverse Events | Any unsolicited adverse event | 34 Participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Participants With Unsolicited Adverse Events | Mild | 8 Participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Participants With Unsolicited Adverse Events | Severe | 8 Participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Number of Participants With Unsolicited Adverse Events | Moderate | 18 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Unsolicited Adverse Events | Severe | 15 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Unsolicited Adverse Events | Probably related to vaccination | 2 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Unsolicited Adverse Events | Any unsolicited adverse event | 43 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Unsolicited Adverse Events | Mild | 10 Participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Unsolicited Adverse Events | Moderate | 18 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Participants With Unsolicited Adverse Events | Mild | 10 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Participants With Unsolicited Adverse Events | Probably related to vaccination | 1 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Participants With Unsolicited Adverse Events | Moderate | 24 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Participants With Unsolicited Adverse Events | Any unsolicited adverse event | 38 Participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Number of Participants With Unsolicited Adverse Events | Severe | 4 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Unsolicited Adverse Events | Any unsolicited adverse event | 42 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Unsolicited Adverse Events | Moderate | 24 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Unsolicited Adverse Events | Severe | 7 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Unsolicited Adverse Events | Mild | 11 Participants |
| Group 4: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Unsolicited Adverse Events | Probably related to vaccination | 2 Participants |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Unsolicited Adverse Events | Mild | 3 Participants |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Unsolicited Adverse Events | Probably related to vaccination | 1 Participants |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Unsolicited Adverse Events | Any unsolicited adverse event | 15 Participants |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Unsolicited Adverse Events | Moderate | 8 Participants |
| Group 5: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Number of Participants With Unsolicited Adverse Events | Severe | 4 Participants |
| Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Unsolicited Adverse Events | Severe | 5 Participants |
| Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Unsolicited Adverse Events | Any unsolicited adverse event | 13 Participants |
| Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Unsolicited Adverse Events | Moderate | 8 Participants |
| Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Unsolicited Adverse Events | Probably related to vaccination | 2 Participants |
| Group 6: IPV-vaccinated - Two Doses of Novel OPV2 Candidate 2 | Number of Participants With Unsolicited Adverse Events | Mild | 0 Participants |
| Group 7: IPV-vaccinated - Two Doses of Placebo | Number of Participants With Unsolicited Adverse Events | Mild | 1 Participants |
| Group 7: IPV-vaccinated - Two Doses of Placebo | Number of Participants With Unsolicited Adverse Events | Any unsolicited adverse event | 17 Participants |
| Group 7: IPV-vaccinated - Two Doses of Placebo | Number of Participants With Unsolicited Adverse Events | Probably related to vaccination | 1 Participants |
| Group 7: IPV-vaccinated - Two Doses of Placebo | Number of Participants With Unsolicited Adverse Events | Severe | 9 Participants |
| Group 7: IPV-vaccinated - Two Doses of Placebo | Number of Participants With Unsolicited Adverse Events | Moderate | 7 Participants |
Secondary
Seroconversion Rate After a Single Dose of Novel OPV2 in Former OPV Recipients
Seroconversion is defined as a change from seronegative to seropositive (poliovirus type-2-specific neutralizing antibody titers ≥ 1:8), or for participants seropositive at Baseline, an antibody titer increase of ≥ 4-fold over Baseline titer.
Time frame: Day 28
Population: Participants in the seroconversion subset of the per-protocol population previously vaccinated with OPV. The seroconversion subset included participants with Baseline titer sufficiently low to enable observation of a four-fold increase without breaching the ULOQ (ie, a titer ≤ 362).~Since this endpoint was analyzed after 1 dose of nOPV, Groups 1 and 2 and Groups 3 and 4 are combined for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Seroconversion Rate After a Single Dose of Novel OPV2 in Former OPV Recipients | 74.5 percentage of participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Seroconversion Rate After a Single Dose of Novel OPV2 in Former OPV Recipients | 51.1 percentage of participants |
Secondary
Seroconversion Rate After Two Doses of Novel OPV2 in Former OPV Recipients
Seroconversion is defined as a change from seronegative to seropositive (poliovirus type-2-specific neutralizing antibody titers ≥ 1:8), or for participants seropositive at Baseline, an antibody titer increase of ≥ 4-fold over Baseline titer.
Time frame: Day 56
Population: Participants in the seroconversion subset of the per-protocol population previously vaccinated with OPV and who received 2 doses of novel OPV2 (Groups 2 and 4). The seroconversion subset included participants with Baseline titer sufficiently low to enable observation of a four-fold increase without breaching the ULOQ (ie, a titer ≤ 362).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Seroconversion Rate After Two Doses of Novel OPV2 in Former OPV Recipients | 74 percentage of participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Seroconversion Rate After Two Doses of Novel OPV2 in Former OPV Recipients | 58 percentage of participants |
Secondary
Seroconversion Rate in Former IPV Recipients
Seroconversion is defined as a change from seronegative to seropositive (poliovirus type-2-specific neutralizing antibody titers ≥ 1:8), or for participants seropositive at Baseline, a poliovirus type-2-specific neutralizing antibody titer increase of ≥ 4-fold over Baseline titer.
Time frame: Day 28 and Day 56
Population: Participants in the seroconversion subset of the per-protocol population previously vaccinated with IPV only. The seroconversion subset included participants with Baseline titer sufficiently low to enable observation of a four-fold increase without breaching the ULOQ (ie, a titer ≤ 362).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Seroconversion Rate in Former IPV Recipients | Day 28 | 100 percentage of participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Seroconversion Rate in Former IPV Recipients | Day 56 | 100 percentage of participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Seroconversion Rate in Former IPV Recipients | Day 28 | 92 percentage of participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Seroconversion Rate in Former IPV Recipients | Day 56 | 82 percentage of participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Seroconversion Rate in Former IPV Recipients | Day 28 | 0 percentage of participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Seroconversion Rate in Former IPV Recipients | Day 56 | 8 percentage of participants |
Secondary
Seroprotection Rate 28 Days After Two Doses of Novel OPV2 in Former OPV Recipients
Seroprotection rate was defined as the percentage of participants with anti-type 2-specific poliovirus neutralizing antibodies titers ≥ 1:8.
Time frame: Day 56
Population: Participants in the per-protocol population previously vaccinated with OPV who received 2 doses of novel OPV2 (Groups 2 and 4).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Seroprotection Rate 28 Days After Two Doses of Novel OPV2 in Former OPV Recipients | 100 percentage of participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Seroprotection Rate 28 Days After Two Doses of Novel OPV2 in Former OPV Recipients | 100 percentage of participants |
Secondary
Seroprotection Rate in Former IPV Recipients
Seroprotection rate was defined as the percentage of participants with anti-type 2-specific poliovirus neutralizing antibodies titers ≥ 1:8.
Time frame: Day 0, Day 28, and Day 56
Population: Participants in the per-protocol population previously vaccinated with IPV only. Samples for 2 participants in Group 5 on Day 0 were mixed up and are not included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Seroprotection Rate in Former IPV Recipients | Day 56 | 100 percentage of participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Seroprotection Rate in Former IPV Recipients | Day 28 | 100 percentage of participants |
| Group 1: OPV-vaccinated - One Dose of Novel OPV2 Candidate 1 | Seroprotection Rate in Former IPV Recipients | Day 0 (pre-vaccination) | 93 percentage of participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Seroprotection Rate in Former IPV Recipients | Day 56 | 100 percentage of participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Seroprotection Rate in Former IPV Recipients | Day 0 (pre-vaccination) | 94 percentage of participants |
| Group 2: OPV-vaccinated - Two Doses of Novel OPV2 Candidate 1 | Seroprotection Rate in Former IPV Recipients | Day 28 | 100 percentage of participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Seroprotection Rate in Former IPV Recipients | Day 56 | 81 percentage of participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Seroprotection Rate in Former IPV Recipients | Day 28 | 75 percentage of participants |
| Group 3: OPV-vaccinated - One Dose of Novel OPV2 Candidate 2 | Seroprotection Rate in Former IPV Recipients | Day 0 (pre-vaccination) | 81 percentage of participants |